eligibility_summary
Inclusion: Adults 18–65 with T-ALL (incl. ETP), MRD ≥0.01% by flow in CR1 after 2 induction phases, CD38+, ECOG ≤2, adequate liver function (bilirubin <2×ULN, AST/ALT <3×ULN), consent, cleared CSF allowed. Exclusion: T-LBL without BM, persistent CSF positivity or baseline testicular disease, obstructive airway disease, active infection, NYHA III/IV or LVEF <40%, HIV+, pregnant/breastfeeding, HBsAg+ or HBV DNA+.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT07021677 (Phase 2, single-arm). Intervention: Daratumumab (Darzalex), a human IgG1κ anti‑CD38 monoclonal antibody, 16 mg/kg IV weekly ×2, if MRD persists, +2 weekly doses. Goal: eradicate minimal residual disease (MRD) in newly diagnosed adult T-ALL patients who remain MRD+ after two induction phases. Mechanism of action: binds CD38 on leukemic cells, induces antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), and apoptosis, also inhibits CD38 ectoenzyme (NADase) activity, lowering adenosine-mediated immunosuppression to enhance anti-leukemic immunity. Targets: CD38-expressing T-ALL blasts (eligibility requires ≥20% CD38+ blasts), engages NK cells, macrophages, and complement via Fcγ receptors, modulates CD38 signaling/adenosine pathway. Outcome focus: MRD conversion and 1-year progression/death risk, safety.